FDA Product Code
FDA Product Code MYA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.1860
510(k) Clearances — 12 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K183100 | Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra | Leica Biosystems Newcastle, Limited | 2018-12-07 | Special | PDF ↗ |
| K170028 | FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis) | Dako Denmark A/S | 2017-12-21 | Traditional | PDF ↗ |
| K122556 | VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11) | Leica Biosystems Newcastle, Ltd. | 2014-05-19 | Traditional | PDF ↗ |
| K120663 | MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI | Dako North America, Inc. | 2013-02-12 | Traditional | PDF ↗ |
| K110215 | CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY | Ventana Medical Systems, Inc. | 2012-12-17 | Traditional | PDF ↗ |
| K081286 | MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1, MODEL M3634 | Dako North America, Inc. | 2009-05-08 | Traditional | PDF ↗ |
| K061360 | NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN ESTROGEN RECE[PTOR ANTIBODY (CLONE SP1) | Lab Vision Corp. | 2006-06-27 | Traditional | PDF ↗ |
| K060227 | VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11) | Vision Biosystems, Inc. | 2006-05-25 | Abbreviated | PDF ↗ |
| K012138 | MODIFICATION TO ACIS (AUTOMATED CELLULAR IMAGING SYSTEM) | Chroma Vision Medical Systems, Inc. | 2002-09-30 | Traditional | PDF ↗ |
| K013148 | BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88) | Biogenex Laboratories | 2002-02-28 | Traditional | PDF ↗ |
| K993957 | DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR | Dako Corp. | 2000-03-03 | Traditional | PDF ↗ |
| K984567 | VENTANA ER PRIMARY ANTIBODY (CLONE 6F11) | Ventana, Inc. | 1999-08-12 | Traditional | PDF ↗ |
Product code MYA · Class II · Hematology. Data: openFDA.